A Retreatment Study With Bortezomib for Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030302
• Other study ID #: CR015814
• Secondary ID: 26866138MMY4039B
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2009
• Last updated: March 7, 2013
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: March 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.

Description:

It will be essential to obtain the Korean clinical data about the efficacy and safety of the re-treatment with bortezomib as well as to analyze its actual pattern. The current trial is a prospective, multi-center, Phase 4, observational study that will be conducted to collect such demographic data as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, the concomitant drugs that are used for re-treatment and the pattern of treatment for patients with multiple myeloma and who were re-treated with injectable bortezomib. Also safety data will be collected. Observational Study -No investigational drug administered

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with multiple myeloma

• Patients who were treated with bortezomib monotherapy or bortezomib combination therapy

• Patients who relapsed after >= six months interval since last dose of bortezomib

• Patients who had a treatment response of higher than partial remission (PR) to the previous bortezomib therapy

• Patients who were fully aware of the objectives and essential procedures of the current trial and then submitted a written informed consent declaring that they will voluntarily participate in the current trial

Exclusion Criteria:

• The current presence of or a past history of hypersensitivity to bortezomib or its constituents

• Severe hepatic dysfunction (AST or ALT at first use>= x 5 upper normal)

• Pregnant women

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• bortezomib
bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To monitor such factors as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, the concomitant drugs that are used for re-treatment and the pattern of treatment.		6-12 months	No
Secondary	Adverse events		at the end of every 3 week cycle	No
Secondary	Overall response rate		6-12 months	No

External Links

•   An Observational, Prospective Analysis of Retreatment with Bortezomib for Multiple Myeloma